BriefCase-Quantification (BC-QTF)
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- BriefCase-Quantification EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- BriefCase-Quantification EUDAMEDBriefCase-Quantification is an Automated Radiological Image Processing Software. FDA UDI
- Model / Reference
- BC-QTF EUDAMEDBC.QTF.4.x.y FDA UDI
- Description
- BriefCase-Quantification is an Automated Radiological Image Processing Software. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018052266 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290018052BC.QTFSH EUDAMED
- Direct Marketing DI
- 07290018052266 EUDAMED
- FDA Product Code
- QIH FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
BriefCase-Quantification is a medical image management and processing system (Nomenclature Code: Z11069092), designed as an active software module for quantifying radiological images. It operates as an algorithm-based component intended to analyze and process medical imaging data, supporting diagnostic workflows in radiology.
The device is supplied as a non-sterile, non-reusable software solution for use on a Linux-based server within a cloud environment. It is classified as Class IIa under FDA regulations (510(k) clearance) and MDR-compliant, with no implantable, reprocessed, or latex-containing components. Authorized by Obelis s.a. (BE-AR-000000106), it carries a unique UDI (7290018052BC.QTFSH) and is intended for single-use in diagnostic imaging applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Aidoc Medical, Ltd. ℅ John Smith Partner Hogan Lovells U.S. LLP Trade ..., Aidoc | Clinical AI, BriefCase-Quantification (K230534) — FDA 510 (k) | Innolitics, BriefCase-Quantification (K241112) — FDA 510 (k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241112 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232083 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242203 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K230534 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K231631 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7290018052BC.QTFSH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aidoc Medical Ltd.
- EUDAMED SRN
- IL-MF-000030988
- FDA Applicant
- Aidoc Medical , Ltd.
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED be52e84c-1828-4492-bfed-f34b14f42e36 85 fields · synced Sep 20, 2026
- FDA UDI 157fa8e2-859a-4988-84bd-c6c39dce6a8c 34 fields · synced May 29, 2026
- FDA 510(k) K241112 1 fields · synced May 18, 2026